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Venticute

Phase 3

Pneumonia | Small molecule | Infectious Disease |Takeda Pharmaceutical Company Limited|Last Updated: May 7, 2012

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindUNCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment1,200
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00074906Venticute in Patients With Pneumonia or Aspiration of Gastric Contents and Intubation/Ventilation/Oxygenation Impairment (BY2001/M1-007)PHASE3 COMPLETED 1,200Nov 1, 2003Jun 1, 2008May 7, 201292 Australia, Austria +15
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Study Endpoints
Primary Endpoints
Survival on day 28
28 days
Secondary Endpoints
How long the lung and the patient (overall) are recovering
28 days
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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT
Interventions
NameTypeDescription
VenticuteDRUGPatients With Pneumonia or Aspiration of Gastric Contents and Intubation/Ventilation/Oxygenation Impairment
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Eligibility Criteria
Age Range12 Years — 85 Years
SexALL
Healthy VolunteersNo
Study Sites92

Main inclusion criteria: * Patient has been intubated due to one of the following primary pulmonary insults: aspiration of gastric contents or pneumonia Main exclusion criteria: * Principal source of infection or sepsis is outside the lung * Severe pre-existing lung disease * Cancer metastatic to...

Countries:AustraliaAustriaBelgiumDenmarkEstoniaFinlandGermanyGreeceHungaryIsraelNetherlandsNew ZealandRussiaSouth AfricaSpainSwitzerlandUnited Kingdom
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